T2DM
Conditions
Interventions
Intervention Group:Mulberry Twig Total Alkaloids Tablets
Dapagliflozin Group:Dapagliflozin
Sponsors
NanJing First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate and able to sign the informed consent form before the trial; 2. Diagnosis of type 2 diabetes mellitus, aged 18-75 years, meeting WHO 1999 diagnostic criteria, treated with one or two glucose-lowering drugs (if combination therapy, sulfonylurea dose = 18.0 kg/m²; 6. No prior treatment with SGLT2 inhibitors or a-glucosidase inhibitors.
Exclusion criteria
Exclusion criteria: 1. For patients with liver disease: Liver function tests show ALT or AST > 3 × ULN, or Total Bilirubin (TBil) > 2 × ULN; 2. Renal disease: Glomerular filtration rate (GFR)1.5 × ULN; 3. Recurrent urinary tract infections; 4. History of drug abuse or alcohol dependence within the past 5 years; 5. Patients with poor compliance and irregular diet/exercise; 6. Use of systemic hormone therapy or drugs affecting cholesterol levels within the last 3 months; 7. Presence of infection or stress state within the last 4 weeks; 8. Pregnant, breastfeeding, or intending to become pregnant; 9. Any other serious condition or comorbidity judged by the investigator: such as severe cardiopulmonary disease, endocrine disease, neurological disorders, tumors, other pancreatic diseases, history of mental illness, alcoholism, or drug abuse; 10. Myocardial infarction, stroke, or cardiovascular event requiring hospitalization within the last 6 months; 11. Participation in other clinical trials within the last 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycated hemoglobin (HbA1c);Blood glucose variability index (including Time in Range, TIR); | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-hour postprandial glucose (2hPG);Blood lipid profile;Fasting venous plasma glucose;Fasting and 2-hour postprandial C-peptide levels;Change in Body Mass Index;Change in Complete Blood Count (CBC) Parameters;HbA1c = 7% achievement rate;Change in Vital Signs;Incidence of Adverse Events (AEs);Change in Liver Function Tests;Change in Renal Function Tests; | — |
Countries
China
Contacts
Public ContactMa Jianhua
NanJing First Hospital
Outcome results
None listed